Medical Affairs/Safety- Director, Product Lead MD - Contract

Title: Medical Reviewer Associate Director
Location: Cambridge or Virtual
Time Zone: EST or CST
Work Arrangement: Hybrid or Remote
Contract: 6 months
Schedule: Full-time, normal business hours

Role Overview
Maternity leave replacement.
Operational Medical Reviewer role; not a people-management position.
Focused on medical review of cases and safety assessment.
Works closely with Safety Leads, Product Leads and teams across the organization.
Expected case volume is approximately 3035 cases per day, with volume potentially higher depending on workload.

Required Experience
Must have MD // Physician/medical training.
Minimum 1 year of clinical practice experience.
Minimum 2+ years of PV experience.
Experience with:
o ICSR medical assessment
o Clinical trials
o Post-marketing cases
o Medical case review
o Signal detection
o Safety/risk assessment
o Regulatory guidelines
o ICH regulations
Must be able to conduct comprehensive case reviews and identify/escalate potential safety risks.
Experience working across multiple therapeutic areas is highly desirable.
Exposure to Phase IIV development, including Phase III clinical trials.

Key Responsibilities
Conduct high-volume medical case reviews.
Review different types of safety cases.
Perform comprehensive medical assessments.
Identify potential risks and safety signals.
Determine when issues require escalation.
Apply regulatory guidelines and ICH requirements.
Work collaboratively with Safety Leads and Product Leads.
Support cases across different development phases and therapeutic areas.

Systems / Technical Skills
ARGUS Safety experience preferred/strong plus.
Experience with signaling tools such as Empirica preferred.
Understanding of safety signaling in a broader PV context is important.

Education / Licensing
MD can be from US or EU ; can not be from anywhere else.
Active Medical license is not required.
Candidates should have completed at least one year of clinical practice/training.

Safety Lead, Contractor, Safety and Risk Management
Summary of Key Responsibilities
Lead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of products.
Be the author and accountable content owner for all safety relevant content or documents during clinical development (e.g. ICF, Risk Language, IB, DSUR, Development RMP) and post approval (e.g. PSUR, RMPs answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters as needed.
Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.
Provide analysis and presentation of safety data in multidisciplinary teams (e. g. Safety Risk Management Teams).
Serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understanding the business strategy for the product, and being knowledgeable about the (medical) context of the respective product class.
Collaborate with SRM colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues.

Qualifications
The ideal candidate will have the following mix of personal and professional characteristics:

MD degree with a minimum of 3 years of medical practice is a must.
Must have a minimum of 3years of pharmaceutical industry experience as a product/program lead within pharmacovigilance
Experience in clinical research/clinical development is a plus.
Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework is required.
Must have sound clinical acumen and a wide range of therapeutic area knowledge.
Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.
Excellent communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
Excellent networking and relationship building skills for successful cooperation with internal and external customers.
Expertise in international regulations governing drug safety and experience in managing compliance through audits and inspections. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.
Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.
Ability to work in fast-paced environment with rapidly approaching timelines is important